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Dow Chemical Company v. Mahlum12/31/1998
term studies on breast implants and other silicone products. In 1967, Dow Corning entered into a j oint research and development agreement with Dow Chemical "relating to the physiological effects resulting from ingestion or injection into the systems of animals or men of particular physiologically active silicones." The two companies also agreed to "jointly share the costs and . . . share the profits and losses of any commercialization."
Also in 1967, Dow Corning implemented a two-year study on miniature Silastic breast implants in dogs, Conducted by an outside laboratory, the Food and Drug Research Laboratories, Incorporated ("FDRL"). An internal Dow Corning memorandum in 1967 referenced that Dr. Rowe was one of the consultants who recommended this study. Although the study appears to have been principally designed by FDRL, part of the testing protocol may have involved Dr. Rowe.
In 1970, Dow Corning enlisted Dow Chemical to conduct a pathology test on the biological effects of DC 360 fluid. Gary Sparschu, a Dow Chemical research pathologist, reported to Dow Corning that the tests showed the liquid silicone had migrated to major organs of the test animals, including the bone marrow, and that the fluid had decreased the brain weights of female rats in two test groups. This information was not shared with the scientific or medical community.
In 1975, Dow Chemical and Dow Corning entered into a trademark agreement wherein Dow Chemical granted Dow Corning the right to use its trade name "Dow" and trademark. In return, Dow Chemical obtained the right to inspect Dow Corning's manufacturing processes to assure the quality of its products and to approve or disapprove any products manufactured, distributed or sold under the Dow Chemical trademark. This agreement also stated that "Dow Company and Corning Company formed [Dow Corning] in 1943 and since then have continuously owned or controlled equally all of the issued share capital of [Dow Corning], and have controlled its operations, including the quality of its goods and services."
Although Dow Corning began selling breast implants in 1362, the record is unclear as to the identity of the silicone fluid used in this early prototype. Dow Corning introduced the Silastic I breast implant, containing DC 360 fluid, in 1975 and the Silastic II breast implant, at issue in this case, in 1982. The Silastic II breast implant was marketed solely under Dow Cornii-ig's trademark and trade name, not Dow Chemicals.
In 1991, the United States Food and Drug Administration ("FDA") conducted a premarket approval program for all manufacturers who wished to continue marketing and distributing silicone gel implants. Dow Corning submitted its premarket approval application to the FDA. Subsequently, the FDA suspended the use of silicone gel implants for cosmetic or augmentation purposes because of' concerns about their safety, and limited their use to urgent medical situations or limited clinical trials.
ii. Facts and Procedural History
The matter at bar is, one of many cases pending across the country wherein breast implant recipients have sued Dow Chemical alleging that it is legally responsible for defects in Dow Corning's silicone breast implants.
In August 1985, as part of reconstructive surgery following a bilateral subcutaneous mastectomy, Charlotte Mahlum elected to receive silicone gel breast prostheses (hereinafter "breast implants"). Dow Corning manufactured the two silastic II breast implants that Mahlum's surgeon implanted. The Silastic II implant is made up of several components. A clear outer shell of silicone rubber called an elastomer contains the silicone gel and is the protec
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